The U.S. Food and Drug Administration has given the injectable Xolair (omalizumab) the green light for use in decreasing the risk of life-threatening reactions to certain foods. Doctors weighed in.
Food allergy sufferers have a new weapon in their fight against severe symptoms.
The U.S. Food and Drug Administration (FDA) has given the injectable Xolair (omalizumab) the green light for use in decreasing the risk of life-threatening reactions to certain foods.
Xolair was approved for "immunoglobulin E-mediated food allergy in certain adults and children 1 year or older," the FDA announced on Feb. 16.
This is the first medication the FDA has approved to reduce allergic reactions after accidental exposure to several types of food, the agency stated.
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Robert A. Wood, M.D., was the principal investigator of the multicenter study that led to the FDA approval.
"Treatment options, aside from strict avoidance, have been very limited for the millions of Americans with severe food allergies," Wood, director of the Division of Pediatric Allergy, Immunology and Rheumatology at Johns Hopkins University School of Medicine in Baltimore, Maryland, told Fox News Digital.
"The lives of these patients and their families are often consumed by fear of accidental exposure to food allergens — and even with strict avoidance, accidental exposures are common."
"The approval of Xolair for the treatment of food allergy will be very meaningful, and potentially even life-changing, for people with food allergies," Wood added.
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Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America (AAFA), a nonprofit headquartered in Maryland, was not involved in the medication research but spoke with Fox News Digital about the recent approval.
"The stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children's birthday parties, school lunches and holiday dinners with friends and family," Mendez said.
"Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies."
Individuals must still avoid foods they're allergic to, even if they take Xolair, the FDA noted in the announcement.
"This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies," Kelly Stone, M.D., PhD, associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.
"While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs."
Xolair, made by Genentech in California, is not approved for the immediate emergency treatment of allergic reactions. It is also not a substitute for current emergency treatments, the federal agency stated.
Such emergency treatments include doses of epinephrine and EpiPens to prevent anaphylaxis, which is a severe allergic reaction that can potentially be fatal, health experts told Fox News Digital.
Nearly 6% of U.S. adults and children suffer from food allergies, according to the Centers for Disease Control and Prevention (CDC) — and more than 40% of children with food allergies in the U.S. have been treated in the emergency department.
Dr. Fred Davis, associate chair of emergency medicine at Northwell Health in New Hyde Park, New York, said he sees a number of allergic reactions from exposure to food.
"This drug may be able to lower that risk," he told Fox News Digital.
"Remember that this is a preventative drug, not a medication to be used after exposure when one is having an acute allergic reaction," Davis cautioned.
"The recent FDA approval of Xolair for food allergies marks another important step forward for the 33 million Americans living with this condition," Dr. Susan Schuval, chief of the Division of Pediatric Allergy/Immunology at Stony Brook Children's Hospital on Long Island, New York, told Fox News Digital.
"Although Xolair is not a cure for food allergies, its use may lessen the risk of severe reactions from accidental food exposures. Patients will still need to practice food avoidance and carry epinephrine injectors," Schuval said.
As there is currently no cure for food allergies, the CDC recommends strict avoidance of any foods that cause them.
Milk, eggs, fish, crustacean shellfish, wheat, soy, peanuts, and tree nuts account for the most serious allergic reactions in the U.S., per the agency.
IgE-mediated food allergies — the most severe — occur when the body’s immune system mistakenly perceives a food particle as a harmful invader.
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A type of antibody called immunoglobulin E (IgE) contributes to the immune response, which can include stomach issues, itching, hives or anaphylaxis, according to several health experts.
Xolair helps dampen this immune response by targeting certain receptors in the body.
"It is an injection that works on blocking IgE, reducing the risk of an allergic reaction, but needs to be taken regularly to work," Davis told Fox News Digital.
The FDA’s approval decision was based on a study that explored the effectiveness and safety of Xolair in 168 participants ranging from babies to adults.
All participants were allergic to peanuts and at least two other foods, which included milk, wheat, egg, walnut, hazelnut or walnut.
Participants received either Xolair or a placebo for 16 to 20 weeks.
Sixty-eight percent of those who received Xolair were able to tolerate the equivalent of 2½ peanuts without a moderate or severe allergic reaction, compared to 6% who took the placebo.
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Also among the participants who received the Xolair injections, 67% of people with egg allergies, 66% of people with milk allergies and 42% of people with cashew allergies were able to consume a single dose (1,000 milligrams or greater) of cashew, milk or egg protein without moderate to severe allergic symptoms.
The agency recommended that an individual should only start the medication in a health care setting equipped to manage anaphylaxis.
Patients should discuss with their health care provider whether Xolair is the right choice for them, experts said.
Fox News Digital reached out to the FDA for additional comment.
